Functional Ingredients: Effect in Gastrointestinal System

Overview

The addition of fructans or unripe banana flour to frozen meals can change the hormonal parameters related to hunger and satiety, improve the bowel movements and increase in colonic bacteria population measured by microbiological determinations (qPCR). The inulin no can change bowel movements and increase in colonic bacteria population measured by microbiological determinations (qPCR)

Full Title of Study: “Functional Ingredients: Effect in Satiety and Intestinal Health”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2012

Detailed Description

Non-transmissible chronic diseases have been constantly related to the consumption of diets with inadequate nutrient input; at the same time, the ingestion of unavailable carbohydrates have presented an inverse relationship with the risk for these diseases. Among these carbohydrates is inulin, a fructan considered as a prebiotic and the unripe banana flour, rich in resistant starch, which may contribute to the intestinal health. This study evaluated the effect of regular intake of frozen soups added functional ingredients (fructans and unripe banana flour) by heath volunteers, about gastrointestinal hormones, satiety and bowel movements.

Interventions

  • Dietary Supplement: Ready-to-eat frozen soups added unripe banana flour
    • Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)
  • Dietary Supplement: Ready-to-eat frozen soups added maltodextrin
    • Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)
  • Dietary Supplement: Ready-to-eat frozen soups added inulin
    • Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)
  • Dietary Supplement: Ready-to-eat frozen soups added nisin
    • Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)

Arms, Groups and Cohorts

  • Experimental: UBF group
    • Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)
  • Placebo Comparator: Control
    • Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)
  • Experimental: Inulin group
    • Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)
  • Experimental: Nisin group
    • Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)

Clinical Trial Outcome Measures

Primary Measures

  • Change in hormonal parameters related to hunger and satiety.
    • Time Frame: 6 weeks
    • Changes in satiety measured by specific hormones kit
  • Change in bowel function
    • Time Frame: 6 weeks
    • Changes measured by GSRS and daily questionnaires
  • Change in colonic bacteria population
    • Time Frame: 6 weeks
    • Changes measured by microbiological analysis by r16SDNA sequencing
  • Change in satiety
    • Time Frame: 6 weeks
    • Changes in satiety measured by Visual Analogue Scale questionnaire.

Secondary Measures

  • Change in biochemical parameters
    • Time Frame: 6 weeks
    • Changes measured by biochemical kit

Participating in This Clinical Trial

Inclusion Criteria

  • good health condition Exclusion Criteria:

  • history of renal or gastrointestinal disease – hyperthyroidism – diabetes, nor parents with diabetes – for women: not pregnant, breastfeeding or using hormonal therapy – using any drug that might affect the digestion of food and absorption (antibiotics, laxatives)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Collaborator
    • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eliana Bistriche Giuntini, PhD – University of Sao Paulo
  • Overall Official(s)
    • Elizabete W Menezes, Prof Assoc, Principal Investigator, Faculty of Pharmaceutical Sciences of University of Sao Paulo

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